Pentosan polysulfate sodium is a semi-synthetically produced heparin which has anticoagulant and fibrinolytic effect. It is used in the treatment of bladder pain and discomfort caused by cystitis (bladder inflammation or irritation).

Product information (PI) of Pentosan polysulfate sodium (‘Section 4.4 Special Warnings and Precautions for Use’ and ‘Section 4.8 Adverse Effects’) are updated with a rare and potentially severe adverse event -pigmentary maculopathy.

Health Authority:

Therapeutic Goods & Administration (TGA) – Health authority of Australia.

Important note for Healthcare professionals:

• Although TGA has not received any case reports pertaining to this drug-ADR pair, safety evidence from global literature suggests potential causal relationship between pentosan polysulfate sodium and pigmentary maculopathy.
• Awareness: Please be aware of this potential risk and inform patients and care providers to monitor for relevant visual signs of this risk which included reading difficulty and slow adjustment to low or reduced light environments. Consider performing ophthalmic evaluation especially in the long term usage of this medicine.
• While prescribing/dispensing/administering minocycline, it is recommended to make patient and patient care providers aware of this risk for early monitoring of visual functioning followed by early drug discontinuation of this drug and alternative treatment initiation (if required).

Important note for Public (Patients/patient care providers):

• Be aware of potential risk pigmentary maculopathy with pentosan polysulfate sodium (brand name: ELMIRON®) and be conscious of your visual function [reading difficulty and slow adjustment to low or reduced light environments] especially during the long term usage of this product.
• Inform your respective healthcare professional or report to your national ADR reporting system for any changes in your visual function followed by the chronic usage of pentosan polysulfate sodium.

Voluntary ADR reporting:

Every medicinal product has both benefits and risks. Medicines are authorized to market based on the favorable benefit-risk profile anticipated at the time of regulatory approval/entry into market. However, the safety profile of medicine would continuously updates owing to safety data from the post marketing experience from public. If the rate of reporting of suspected adverse drug reactions (ADR) from public is line with the actual occurrence of ADRs, the time lapse for taking regulatory action can be reduced and thereby improving patient safety.

All health care professionals and consumers of pharmaceutical medicinal products are encouraged to be aware of this fact and observe/monitor for any possible adverse events, reactions, medication errors, or quality complaints of medicinal products and report the same to your respective national health authority.

This would accumulate safety evidence for medicinal products which in turn help health authorities to take regulatory actions at the earliest possibility for a better patient safety and overall public health.